Katalyst Healthcares and Life Sciences
Responsibilities:
- Experience in integrations/acquisitions with respect to ensuring quality requirements are preserved pre-post integration.
- Presentation of results in a logical and clear manner.
- bility to analyse information and come to conclusions based on presented data.
- bility to communicate effectively both orally and in writing.
- Strong organizational and interpersonal skills.
- bility to learn and utilize computer in standard business applications including electronic document control, word processing, spreadsheets and databases.
- Background in statistics with respect to process control (reliability, capability, SPC, etc.)
- BS degree in Life Science, Engineering or equivalent program is preferred.
- t least 5 years of experience in the medical device industry.
- NCMR, CAPA, Change control and GDP experience.
- Ideally both in transferring/scaling up existing processes as well as developing new processes.
- Process validation (IQ/OQ/PQ/TMV/MSA).
- 21CFR820, ISO13485:2016, ISO14971.